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A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02316106
Recruitment Status : Active, not recruiting
First Posted : December 12, 2014
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

December 10, 2014
December 12, 2014
February 2, 2018
May 20, 2015
August 8, 2017   (Final data collection date for primary outcome measure)
  • The percentage of participants who achieve a complete response (CR) [ Time Frame: Up to approximately 24 months ]
    CR, defined having negative immunofixation on the serum and urine, and <5% plasma cells (PCs) in bone marrow.
  • The percentage of participants that have an event (disease progression or death) per patient-year [ Time Frame: Up to approximately 30 months ]
Same as current
Complete list of historical versions of study NCT02316106 on ClinicalTrials.gov Archive Site
  • The percentage of participants who are minimal residual disease (MRD) negative [ Time Frame: Up to 5.5 years ]
  • Time to next treatment (TNT) [ Time Frame: Up to 5.5 years ]
    TNT, defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment.
  • The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR) [ Time Frame: Up to 5.5 years ]
    See definition of CR above. PR, defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours.
  • The median time of progression free survival (PFS) [ Time Frame: Up to 5.5 years ]
    PFS, defined as the time from the date of randomization to the date of initial documented disease progression (PD) or date of death, whichever occurs first.
  • The percentage of participants with symptomatic multiple myeloma [ Time Frame: Up to 5.5 years ]
  • Response to first subsequent multiple myeloma treatment [ Time Frame: Up to 5.5 years ]
  • Overall survival rate [ Time Frame: Up to 5.5 years ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicenter study of daratumumab in participants diagnosed with intermediate or high-risk Smoldering Multiple Myeloma (SMM [ie, early disease without any symptoms]). Participants will be randomized (assigned by chance) to one of 3 treatment groups to receive daratumumab. Each treatment group will investigate 1 of 3 dosing schedules of daratumumab. The study will include a 28-Day Screening Phase, a Treatment Phase of 1 to 20 treatment cycles (each cycle is 8 weeks in duration for total period of 8 to 160 weeks), and a Follow up Phase of 4-weeks from the last dose of study drug. The Follow-up Phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. The end of the study will occur approximately 4 years after the last participant enrolled receives a first dose of study drug. Disease assessments will be performed every 8 weeks in the first year and then every 16 weeks until disease progression. Safety will be monitored throughout the study.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: daratumumab
    16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. Treatment cycles are 8 weeks in length.
  • Drug: daratumumab
    16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20. Treatment cycles are 8 weeks in length.
  • Drug: daratumumab
    16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length.
  • Experimental: Arm A (Long Intense)
    Intervention: Drug: daratumumab
  • Experimental: Arm B (Intermediate)
    Intervention: Drug: daratumumab
  • Experimental: Arm C (Short Intense)
    Intervention: Drug: daratumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
126
120
July 20, 2020
August 8, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
  • Have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

  • Active multiple myeloma,requiring treatment as defined by the study protocol
  • Primary systemic AL (immunoglobulin light chain) amyloidosis
  • Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
  • History of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
  • Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
  • Any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czechia,   France,   Germany,   Israel,   Netherlands,   Russian Federation,   Turkey,   United Kingdom,   United States
Czech Republic
 
NCT02316106
CR106449
54767414SMM2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005139-14 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP